Cedar Pollinosis Clinical Trial
Official title:
A Phase 1 Study of ASP4070 to Confirm the Safety and Immunological Response in Patients With Cedar Pollinosis When Administered as Intramuscular Vaccination and as Intradermal Vaccination
Examine safety and immunological response for ASP4070 when vaccinated in patients with pollen allergy
This study consists of 2 parts: Part 1 and Part 2. [Part 1] An open-label, un-controlled
study Examine the safety for the ASP4070 intramuscular vaccination group (high dose x 4
times) and the ASP4070 intradermal vaccination group (high dose x 4 times).
[Part 2] A placebo-controlled, double-blinded, randomized, parallel-group comparative study
Assess the immunological response and safety for the ASP 4070 intramuscular vaccination group
(high dose x 1 time and high dose x 4 times) and the ASP4070 intradermal vaccination group
(low dose x 1 time, low x 4 times, high dose x 1 time, and high dose x 4 times) as compared
to those for the placebo group. The study will be double-blinded within the same route of
vaccination, and non-blinded between the routes of vaccination (between the intramuscular
vaccination group and intradermal vaccination group).
The first vaccination to the subjects in Part 2 will start at least 14 days after the first
vaccination to the subjects in Part 1 (6 subjects).
For both Part 1 and Part 2, primary study period is for 3 months starting from the last dose
of the study drug at Day 43 (until Day 127). After the primary study period, safety
information will be collected for 9 months (for 1 year from the last dose of the study drug)
as the long-term safety follow-up study period. Safety information will be collected for 1
year starting from the last vaccination of the study drug also from the patients who
discontinued the participation in the study during the primary study period if the patients
agree.
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